HomeProductionSr Manager/Manager | Topicals R&D | Marksans Pharma Ltd | Navi Mumbai

Sr Manager/Manager | Topicals R&D | Marksans Pharma Ltd | Navi Mumbai

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We have established world-class manufacturing facilities by leveraging state-of-the-art technology, incorporating best practices, and adhering to stringent regulatory compliances. Our plants are approved by the prestigious US FDA, UK MHRA, Australian TGA, and other foreign health authorities.

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Life at Marksans means an opportunity for ample learning, growth, and fun at work. We recognize that our business depends on the creativity, dedication, and performance of our employees. We encourage them to focus on achievement through collaboration and innovation.

We value the diversity that exists within our employees and leverage this to bring about synergy within the organization. This enables individuals and groups to contribute to their fullest potential.

“The essence of our culture is built on meeting global standards in every aspect of our business.”

Position: Sr Manager/Manager – Topicals R&D

Location: Navi Mumbai, Maharashtra, India

Job Description:

  • Establish the necessary infrastructure and capabilities required for the development and scale-up of topical dosage forms like creams, ointments, gels, etc for filing in highly regulated markets like the US.
  • Evaluate the portfolio/assigned project with regards to technical aspects like complexity; developability, manufacturability & timelines. Prepare a project plan for this.

     

  • Evaluate the reference product suitably and define the QTPP and other development requirements. Evaluate the patent & regulatory landscape and develop a development approach in collaboration with stakeholders.

     

  • Perform a literature search and other suitable experiments in the pre-formulation phase. Evaluate the data in order to arrive at the conclusions of the pre-formulation phase.

     

  • Design and execute lab experiments/trials in line with the defined development strategy. Evaluate the data and further the experiments to reach the lab prototype.

     

  • Collaborate with CROs to perform the in-vitro and in-vivo testing of topical dosage forms as per guidelines. Identify the requirements, evaluate CRO capability, shortlist CROs, finalize protocols, and monitor the study.

     

  • Define the manufacturing process and perform experiments/trials in order to optimize and characterize the process.

     

  • Write and provide the technical documentation package to the manufacturing site for the registration batches. Work closely with the site in order to define the scale-up, registration batches/ process validation batches strategy.

     

  • Execute the scale-up / registration/ process validation batches at the manufacturing site in close collaboration with the site team.

     

  • Provide the technical document package for filing in collaboration with stakeholders. Provide technical guidance and data required for the registration phase.

     

  • Provide technical support on quality issues, improvements on commercial lifecycle products.

Desired Candidate Profile:

  • Around 15 years of formulation development and technology transfer experience of topical dosage forms for the US.
  • Must be experienced in the formulation development and scale-up of creams, ointments, and gels.
  • Must have knowledge and experience for the entire development cycle like pre-formulation, formulation development, scale-up & tech transfer & in-vitro/in-vivo studies.
  • Experience in setting up a development infrastructure for topical semi-solid development.
  • The position is responsible to perform the formulation design, development, process development, technology transfer, and approval of generic pharmaceutical products with a special focus on topical dosage forms for highly regulated markets.
  • Within approved guidelines on quality, cost & timelines.

Qualification: M.Pharma – Pharmaceutics from Reputed Institute/University

Experience: 14-15 Years

Salary: Negotiable

Contact Details:

pradnya.patel@marksanspharma.com 

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